EXPEDIUM 179778480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034393117), received between Nov 12, 2019 and Nov 13, 2019 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K082942, K111136); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9315147 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9315123 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9311000 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082942, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467